País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LENALIDOMIDEHYDROCHLORIDE 1-WATER 6,1 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 5 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
L04AX04
LENALIDOMIDEHYDROCHLORIDE 1-WATER 6,1 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
Lenalidomide
2018-11-20
Lenalidomide, NL/H/4068/001-007, 08.03.2023 1 rvg 121419_33_34_36_38_41_46 EU PIL IB/024/G met NL info-tracked BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER LENALIDOMIDE RATIOPHARM 2,5 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 5 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 7,5 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 10 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 15 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 20 MG, HARDE CAPSULES LENALIDOMIDE RATIOPHARM 25 MG, HARDE CAPSULES lenalidomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR WHAT [PRODUCT NAME] IS [Product name] contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT {PRODUCT NAME] IS USED FOR [Product name] is used in adults for • Multiple myeloma • Myelodysplastic syndromes • Mantle cell lymphoma • Follicular lymphoma MULTIPLE MY ELOMA Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear fo Llegiu el document complet
Lenalidomide, NL/H/4068/001-007, 08.03.2023 1 rvg 121419_33_34_36_38_41_46 EU SPC IB/024/G met NL info-tracked SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Lenalidomide ratiopharm 2,5 mg, harde capsules Lenalidomide ratiopharm 5 mg, harde capsules Lenalidomide ratiopharm 7,5 mg, harde capsules Lenalidomide ratiopharm 10 mg, harde capsules Lenalidomide ratiopharm 15 mg, harde capsules Lenalidomide ratiopharm 20 mg, harde capsules Lenalidomide ratiopharm 25 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 2.5 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 2.5 mg of lenalidomide. [Product name] 5 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 5 mg of lenalidomide. [Product name] 7.5 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 7.5 mg of lenalidomide. [Product name] 10 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 10 mg of lenalidomide. [Product name] 15 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 15 mg of lenalidomide. [Product name] 20 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 20 mg of lenalidomide. [Product name] 25 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 25 mg of lenalidomide. Excipients with known effect: [Product name] 2.5 mg hard capsules: Each capsule contains 0.5 mg of sodium. [Product name] 5 mg hard capsules: Each capsule contains 0.5 mg of sodium. [Product name] 7.5 mg hard capsules: Each capsule contains 0.67 mg of sodium. [Product name] 10 mg hard capsules: Each capsule contains 0.9 mg of sodium. [Product name] 15 mg hard capsules: Each capsule contains 1.35 mg of sodium. [Product name] 20 mg hard capsules: Each capsule contains 1.80 mg of sodium. Lenalidomide, NL/H/4068/001-007, 08.03.2023 2 rvg 121419_33_34_36_38_41_46 EU SPC IB/024/G Llegiu el document complet